510(k) · Cleared
ClearedEnsite Velocity System V1.3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DQK Computer, Diagnostic, Programmable
Cleared on Feb 25, 2010 after a 65-day review. The FDA summary names no predicate by number. 119 later devices descend from it.
- Decided
- Feb 25, 2010
- Review
- 65 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
119 later devices descend from it, 3 citing it directly.
- This deviceK093942 Ensite Velocity System V1.3St Jude Medical · 2010
- Descendant · cites it directly · 66 of its ownK101419 Ensite Velocity System, Model EE3000St Jude Medical · 2010
- Descendant · cites it directly · 50 of its ownK101667 Ensite Velocity System Referred to Ensite Velocity System with…St Jude Medical · 2010
- Descendant · 2 generations on · 48 of its ownK112688 Ensite Velocity System V.3.0St Jude Medical · 2011
- Descendant · 3 generations on · 46 of its ownK130594 Ensite Velocity SystemSt Jude Medical · 2013
- Descendant · 2 generations on · 36 of its ownK111905 Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K101419Ensite Velocity System, Model EE3000St Jude Medical · 2010 · cites it directly66descendants
- K101667Ensite Velocity System Referred to Ensite Velocity System with Positional Reference Tool…St Jude Medical · 2010 · cites it directly50descendants
- K112688Ensite Velocity System V.3.0St Jude Medical · 2011 · 2 generations on48descendants
- K130594Ensite Velocity SystemSt Jude Medical · 2013 · 3 generations on46descendants
- K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2011 · 2 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093942 | Ensite Velocity System V1.3 | St Jude Medical | 2010 | — |
| +1 | K101419 | Ensite Velocity System, Model EE3000 | St Jude Medical | 2010 | — |
| +1 | K101667 | Ensite Velocity System Referred to Ensite Velocity System with Positional… | St Jude Medical | 2010 | — |
| +2 | K112688 | Ensite Velocity System V.3.0 | St Jude Medical | 2011 | — |
| +3 | K130594 | Ensite Velocity System | St Jude Medical | 2013 | — |
| +2 | K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 10 | 0 |
| 2024 | 11 | 0 |
| 2025 | 15 | 0 |
| 2026 | 12 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (119)
See all 1193 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101419 (St Jude Medical, 2010) has gone furthest, with 66 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The EnSite VelocityTM Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.
*When used with the EnSite Array'TM Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
OR
*When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093942 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093942: Ensite Velocity System V1.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093942
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026